Product profile · United States

KISQALI

· Patent Litigation & Settlement History ↓

IngredientRIBOCICLIB SUCCINATE

Application typeNDA

Application209092

Product001

Dosage formTABLET

RouteORAL

StrengthEQ 200MG BASE

Approval date2017-03-13

Marketing statusPrescription

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year2031

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2031-09-13

Patent anchor2031-09-13

Exclusivity anchor2022-03-13

Protection date2036-10-14

First Final ANDA—

Status event—

Canonical 2031-09-13; DEEP_REVIEW; latest post-anchor right 2036-10-14; Final exact ANDA link not identified; not certified generic absence.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8324225	2028-06-17	DS/DP —	—	—	—	—	—	—
8324225	2028-12-17	— —	—	—	—	—	2028-12-17	—
8324225	2028-12-17	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	2028-12-17	—
9416136	2029-08-20	U U-2356	—	—	—	—	—	—
9416136	2029-08-20	U U-3265	—	—	—	—	—	—
9416136	2029-08-20	U U-3999	—	—	—	—	—	—
9416136	2029-08-20	U U-1981	—	—	—	—	—	—
9416136	2029-08-20	U U-2355	—	—	—	—	—	—
9416136	2029-08-20	U U-3266	—	—	—	—	—	—
9416136	2029-08-20	U U-3975	—	—	—	—	—	—
8962630	2029-12-09	U U-1981	—	—	—	—	—	—
8962630	2029-12-09	U U-2355	—	—	—	—	—	—
8962630	2029-12-09	U U-3266	—	—	—	—	—	—
8962630	2029-12-09	U U-3975	—	—	—	—	—	—
8962630	2029-12-09	U U-2356	—	—	—	—	—	—
8962630	2029-12-09	U U-3999	—	—	—	—	—	—
8962630	2029-12-09	U U-3265	—	—	—	—	—	—
9416136	2030-02-20	— —	—	—	—	—	2030-02-20	—
9416136	2030-02-20	ORANGE_BOOK U-1981,U-2355,U-2356,U-3265,U-3266,U-3975,U-3999	N	Y	DS_EQUIVALENT English description not available.	—	2030-02-20	—
8685980	2030-05-25	DS/DP —	—	—	—	—	—	—
8962630	2030-06-09	— —	—	—	—	—	2030-06-09	—
8962630	2030-06-09	ORANGE_BOOK U-1981,U-2355,U-2356,U-3265,U-3266,U-3975,U-3999	N	Y	DS_EQUIVALENT English description not available.	—	2030-06-09	—
8685980	2030-11-25	— —	—	—	—	—	2030-11-25	—
8685980	2030-11-25	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	2030-11-25	—
8415355	2031-03-13	DS/DP —	—	—	—	—	—	—
8415355	2031-09-13	— —	—	—	—	—	2031-09-13	—
8415355	2031-09-13	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	2031-09-13	—
9193732	2031-11-09	DS/DP —	—	—	—	—	—	—
9868739	2031-11-09	U U-1981	—	—	—	—	—	—
9868739	2031-11-09	U U-3975	—	—	—	—	—	—
9868739	2031-11-09	U U-2355	—	—	—	—	—	—
9868739	2031-11-09	U U-3999	—	—	—	—	—	—
9868739	2031-11-09	U U-2356	—	—	—	—	—	—
9868739	2031-11-09	U U-3265	—	—	—	—	—	—
9868739	2031-11-09	U U-3266	—	—	—	—	—	—
9193732	2032-05-09	— —	—	—	—	—	2032-05-09	—
9193732	2032-05-09	ORANGE_BOOK —	N	N	DP English description not available.	—	2032-05-09	—
9868739	2032-05-09	— —	—	—	—	—	2032-05-09	—
9868739	2032-05-09	ORANGE_BOOK U-1981,U-2355,U-2356,U-3265,U-3266,U-3975,U-3999	N	N	U English description not available.	—	2032-05-09	—
12544379	2034-08-07	U U-3975	—	—	—	—	—	—
12544380	2034-08-07	U U-4404	—	—	—	—	—	—
12544380	2034-08-07	U U-4405	—	—	—	—	—	—
12544379	2035-02-07	— —	—	—	—	—	2035-02-07	—
12544379	2035-02-07	ORANGE_BOOK U-3975	N	N	U English description not available.	—	2035-02-07	—
12544380	2035-02-07	— —	—	—	—	—	2035-02-07	—
12544380	2035-02-07	ORANGE_BOOK U-4404,U-4405	N	N	U English description not available.	—	2035-02-07	—
10799506	2036-04-14	DP —	—	—	—	—	—	—
12064434	2036-04-14	DP —	—	—	—	—	—	—
12419894	2036-04-14	DP —	—	—	—	—	—	—
10799506	2036-10-14	— —	—	—	—	—	2036-10-14	—
10799506	2036-10-14	ORANGE_BOOK —	N	N	DP English description not available.	—	2036-10-14	—
12064434	2036-10-14	— —	—	—	—	—	2036-10-14	—
12064434	2036-10-14	ORANGE_BOOK —	N	N	DP English description not available.	—	2036-10-14	—
12419894	2036-10-14	— —	—	—	—	—	2036-10-14	—
12419894	2036-10-14	ORANGE_BOOK —	N	N	DP English description not available.	—	2036-10-14	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
I-783	2018-07-18	2021-07-18	EXPANDED INDICATION TO INCLUDE RIBOCICLIB WITH AN AROMATASE INHIBITOR IN PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY	N	N	—		Source
I-784	2018-07-18	2021-07-18	RIBOCICLIB WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY	N	N	—		Source
NCE	2017-03-13	2022-03-13	English description not available.	Y	Y	—		Source
NPP	2021-12-10	2024-12-10	English description not available.	N	N	—		Source
I-950	—	2027-09-17		—	—	—	—	Source
I-950	2024-09-17	2027-09-17	IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE	N	N	—		Source
PED	—	2028-03-17		—	—	—	—	Source
PED	2027-09-17	2028-03-17	English description not available.	N	N	—		Source
M-14	—	2029-07-01		—	—	—	—	Source
M-14	2026-07-01	2029-07-01	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION	N	N	—		Source
PED	—	2030-01-01		—	—	—	—	Source
PED	2029-07-01	2030-01-01	English description not available.	N	N	—		Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (21)

Type	Date	Role	Basis	Source
PATENT	2028-12-17	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2030-02-20	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2030-06-09	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2030-11-25	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2031-09-13	CANONICAL_ANCHOR	English description not available.	Source
PATENT	2032-05-09	FTO_TAIL	English description not available.	Source
PATENT	2032-05-09	FTO_TAIL	English description not available.	Source
PATENT	2035-02-07	FTO_TAIL	English description not available.	Source
PATENT	2035-02-07	FTO_TAIL	English description not available.	Source
PATENT	2036-10-14	FTO_TAIL	English description not available.	Source
PATENT	2036-10-14	FTO_TAIL	English description not available.	Source
PATENT	2036-10-14	FTO_TAIL	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	EXPANDED INDICATION TO INCLUDE RIBOCICLIB WITH AN AROMATASE INHIBITOR IN PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	RIBOCICLIB WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_STATUS	2031-09-13	CANONICAL_DECISION	Canonical 2031-09-13; DEEP_REVIEW; latest post-anchor right 2036-10-14; Final exact ANDA link not identified; not certified generic absence.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.